JANSSEN PRODS — Yondelis FDA Summary Review (NDA/BLA 207953, 2015)
Johnson & Johnson · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA reviewed trabectedin (Yondelis) for unresectable or metastatic leiomyosarcoma or liposarcoma, based primarily on the ET743-SAR-3007 trial. This randomized, open-label study compared trabectedin to dacarbazine, demonstrating a statistically significant improvement in investigator-assessed progression-free survival (PFS) for trabectedin (median 4.2 months vs. 1.5 months). However, no significant improvement in overall survival was observed. While trabectedin's safety profile includes serious adverse reactions like neutropenic sepsis, rhabdomyolysis, hepatotoxicity, and cardiomyopathy, it was deemed acceptable given the severity of the disease.
Key findings — cited to the page
| incidence of Grade 3 or 4 cardiomyopathy in dacarbazine-treated patients | 1.2 % | · p.24 |
| incidence of Grade 3 or 4 CPK elevations in dacarbazine-treated patients | 0.6 % | Protocol ET743-SAR-3007 · p.24 |
| incidence of Grade 3 or 4 CPK elevations in trabectedin-treated patients | 6 % | Protocol ET743-SAR-3007 · p.24 |
| incidence of Grade 3 or 4 cardiomyopathy in trabectedin-treated patients | 4 % | · p.24 |
| median time to development of Grade 3 or 4 cardiomyopathy in trabectedin-treated patients | 5.3 months | · p.24 |
| incidence of Grade 3-4 elevated liver function tests in trabectedin-treated patients | 35 % | · p.24 |
| incidence of Grade 3 or 4 neutropenia | 43 % | · p.24 |
| median time to first occurrence of Grade 3 or 4 neutropenia | 16 days | · p.24 |
| HR for progression-free survival | 0.55 | Protocol E743-SAR-3007 · p.19 |
| p-value for overall survival | 0.49 | Protocol E743-SAR-3007 · p.19 |
| median progression-free survival (months) | 1.5 months | Protocol E743-SAR-3007 · p.19 |
| deaths from soft tissue malignancies | 4870 | United States · p.4 |
Source: Johnson & Johnson ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →